November 2018

Who Gets to Speak for Earth? Thoughts on the Anniversary of the Arecibo Message

November 15, 2018
International Law, New Technology, Space Law

Will Dooling, MJLST Staffer

November 16th marks the 43rd anniversary of the Arecibo message, an attempt to broadcast a powerful radio signal from the Arecibo Radio Telescope in Puerto Rico to the heart of the Messier 13 galaxy, more than 25,000 light years away. The Arecibo message was largely ceremonial, or experimental, no one seriously expects to hear back. However, the experiment posed interesting questions about how, exactly, humans ought to go about broadcasting messages to extraterrestrials, and who gets to speak for humanity.

If these questions seem far-fetched, that is only because we, as a society, have grown less ambitious in our hopes for space exploration. In the heady days of the early space race, these questions were seriously considered by NASA and the UN. The Arecibo Message was not a lone experiment: both the Pioneer and Voyager space probes, launched at about the same time as the Arecibo message, carried plaques designed to be easily deciphered by whoever, or whatever, would happen upon them in the future. Four decades later, well into the 21st century, we have the first signs of a robust private space industry and serious proposals in place for mining asteroids and lunar tourism but we still have not resolved the questions posed by the Arecibo Message. Who gets to speak for humanity? Should we even be broadcasting right now?

Currently, several large-scale projects are in place with the primary purpose of locating extraterrestrial life in solar systems beyond our own. By far the most ambitious are the continuing efforts of the SETI (Search for Extraterrestrial Intelligence) Institute. SETI is a United States nonprofit organization funded almost entirely by private charitable donations. Some of its largest donors include tech giants William Hewlitt, David Packard, and Paul Allen. SETI largely devotes its time to hunting for radio signals using telescope arrays all over the world. SETI uses this approach because it is relatively easy to hunt for unusual radio signals. A few nations have tried more direct attempts: NASA’s space-based Kepler telescope, and a related French mission called COROT, both launched in part to analyze the chemical composition of planets in nearby solar systems, to see if they could detect chemical compounds that could only form on planets with complex biospheres. FAST (the Five-hundred-meter Aperture Spherical Telescope), completed in 2016, is the largest conventional radio receiver on earth, it was built by China in part to hunt for extraterrestrial radio sources in a manner similar to the US’s SETI.

All these are attempts to locate extraterrestrial life. What should we do if we find any, and should we be sending any more messages in the meantime? The past few years have seen a renewed interest in actively contacting extraterrestrials via Arecibo-like radio broadcasts. (See for example 2017’s Tromsø broadcast from a radio observatory in Norway to the nearby red dwarf star GJ 273). There have even been proposed commercial broadcasts where customers could pay for the novel experience of having personal messages broadcast into space. This increased interest in broadcasting has provoked some controversy: In 2016, a group of prominent “futurists” including astronomer Lucianne Walkowicz and Tesla CEO Elon Musk signed and circulated a letter objecting to any active attempts to contact extraterrestrial life. The letter expressed concern that the content of any deliberate communications should result from international consensus not “a decision based upon the wishes of a few individuals with access to powerful communications equipment.” The letter called for “vigorous international debate by a broadly representative body prior to engaging further in this activity.” It opened with an even more dire observation: “We know nothing of ETI’s [Extraterrestrial Intelligence’s] intentions and capabilities, and it is impossible to predict whether ETI will be benign or hostile.”

Ultimately, active communication with extraterrestrial life is an issue rather like the militarization of space and climate change. It is an international problem that requires international regulatory solutions. Individual actors have little incentive to self-regulate: the presence of any single unregulated actor makes the regulation ineffective. Neither the United Nations Committee on the Peaceful Uses of Outer Space nor the United Nations Office for Outer Space Affairs has taken a position on attempts to broadcast to extraterrestrial civilizations, though they could,and perhaps they should.

It is possible this is not an issue worth considering. It is possible that we are alone in the universe and there is nothing out there to hear us, through this would raise troubling questions of its own. It would mean humanity was a freak exception in an otherwise empty universe. It would mean that every other planet, around every other star, was completely devoid of life. It would be, in a word, weird. The alternative, only slightly less weird, is that something out there has the potential to hear us someday. In the meantime, perhaps we should engage in “vigorous international debate” on this issue while it is still merely speculative.

Access Denied: Fifth Amendment Invoked to Prevent Law Enforcement From Accessing Phone

November 12, 2018
Constitutional Law, Criminal Law, Privacy

Hunter Moss, MJLST Staffer

Mobile phones are an inescapable part of modern life. Research shows that 95% of Americans carry some sort of cell phone, while 77% own smartphones. These devices contain all sorts of personal information, including: call logs, emails, pictures, text messages, and access to social networks. It is unsurprising that the rise of mobile phone use has coincided with an increased interest from law enforcement. Gaining access to a phone could provide a monumental breakthrough in a criminal investigation.

Just as law enforcement is eager to rummage through a suspect’s phone, many individuals hope to keep personal data secret from prying eyes. Smartphone developers use a process called encryption to ensure their consumers’ data is kept private. In short, encryption is a process of encoding data and making it inaccessible without an encryption key. Manufacturers have come under increasing pressure to release encryption keys to law enforcement conducting criminal investigations. Most notable was the confrontation between the F.B.I. and Apple in the wake of the San Bernardino shooting. A magistrate judge ordered Apply to decrypt the shooter’s phone. The tech giant refused, stating that granting the government such a power would undermine the security, and the privacy, of all cellphone users.

The legal theory of a right to privacy has served as the foundation of defenses against government requests for cellphone data. These defenses have been couched in the Fourth Amendment, which is the Constitutional protection guaranteeing security against unreasonable searches. In a ruling that will have profound implications for the future of law enforcement, the Fourth Amendment protection was first extended to mobile phone data when the Supreme Court decided Carpenter v. United States in early 2018. The holding in Carpenter necessitates that warrants are granted during any government investigation seeking to obtain mobile phone records from service providers.

A case from Florida was the most recent iteration of a novel legal theory to shield smartphone users from government encroachment. While the Carpenter decision relied on the Fourth Amendment’s right to privacy, last week’s ruling by the Florida Court of Appeals invokes the Fifth Amendment to bar law enforcement agents from compelling suspects to enter their passcodes and unlocking their phones. This evolution of the Fifth Amendment was grounds for the court to quash a juvenile court’s order for the defendant to reveal his password, which would relinquish the privacy of his phone.

The Fifth Amendment is the constitutional protection from self-incrimination. A suspect in a criminal case cannot be compelled to communicate inculpatory evidence. Because a phone’s passcode is something that we, as the owners, “know,” being forced to divulge the information would be akin to being forced to testify against oneself. While mobile phone users might feel relieved that the development of Fifth Amendment is expanding privacy protections, smartphone owners shouldn’t be too quick to celebrate. While the Fifth Amendment might protect what you “know,” it does not protect what you “are.” Several courts have recognized that the police may unlock a phone using a suspect’s fingerprint or facial recognition software. Given that fingerprinting and mug shots are already routine procedures during an arrest, courts have been reluctant to view unlocking a phone in either manner as an additional burden on suspects.

Technology has seen some incredible advancements over the last few years, particularly in the field of mobile devices. Some have even theorized that our phones are becoming extensions of our minds. The legal framework providing constitutional protections supporting the right to privacy and the right against self-incrimination have trailed the pace of these developments. The new string of cases extending the Fifth Amendment to cellphone searches is an important step in the right direction. As phones have become a ubiquitous part of modern life, containing many of our most private and intimate information, it is clear that the law must continue to evolve to ensure that they are safeguarded from unwanted and unlimited government intrusion.

Impact of China’s Generics Push on Innovator Drug Companies

November 12, 2018
Food and Drug Law, Intellectual Property, Regulatory

Sherrie Holdman, MJLST Staffer

With a population of 1.42 billion, China presents a large market for both innovator manufacturer and generic drug companies. Currently, about 95% of marketed drugs are sold by generics. However, many patients in China opt to use more expensive, imported, brand-name drugs. In an effort to address this problem, China’s State Council has announced its “Opinions Concerning Reforms of Policies to Improve the Supply and Utilization of Generics” to encourage the people of China to use generic drugs early this year. As a regulatory document, the Opinion shed light on the future direction of China’s generic market.

The Opinion identifies three important suggestions to guide implementation. The first suggestion is to promote research and development of generic drugs in China. The Opinion proposes a drug list to be compiled that identifies drugs for which generic counterparts don’t exist yet. The Opinion also encourages the government to develop key technologies in manufacturing generics. The second suggestion aims to improve the quality and efficacy of generic drugs. Generics will only be approved if their quality and efficacy are equivalent to the original drugs. To facilitate this goal, the State Council proposes speeding up the conformity assessment of quality and efficacy of generic drugs and improving the quality management of generic drugs. The third suggestion is to provide policy incentives for generics development, including implementation of a tax policy for generic manufacturers. Under this policy, a generic manufacturer, once designated as a “high technology enterprise,” will have a preferential tax rate of 15%, compared to the 25% rate for other companies. In order to be a “high technology enterprise,” the generic manufacturer will need to meet certain qualifications. Meanwhile, the Opinion encourages patentees to voluntarily grant compulsory licenses to Chinese generic manufacturers when there is “a serious threat to the public health.” However, despite its long existence in Chinese patent law and regulation, the compulsory licenses are historically rare in practice, partly because of the difficulty in defining what constitutes a “serious threat to the public health.”

In order to balance the interests of innovator and generic drug companies, the Opinion provides recommendations for strengthening the enforcement of intellectual property rights. For example, the Opinion proposes establishing an “early warning patent system” to prevent generic manufacturers from infringing on valid patents and thus mitigating the risk of infringement. Moreover, the State Council proposed to enhance accessibility of innovative drugs, especially imported oncology drugs, by applying no tariffs on imported new drugs. A five-year patent extension for new drugs was also proposed to enhance the intellectual property protection of innovator drugs.

Following the announcements promulgated in the Opinion, on April 25, 2018, China Food and Drug Administration (CFDA) released its “Public Comment Draft of Pharmaceutical Data Exclusivity Implementing Rules (provisional).” The Draft proposes that “innovative new drugs” will enjoy six years of data protection and “innovative therapeutic biologics” will enjoy 12 years of data protection. By proposing data protection for new drugs, China encourages multinational corporations to include China in international multicenter clinical trials and to concurrently apply for market introduction in China. Even if the new drug is introduced to China at a later time, the drug will still be entitled to a data protection period (e.g., from one to five years). The public comment period for the Draft was closed on May 31, 2018 and the final rule is expected soon.

Facing China’s generics push, innovator drug makers can strengthen their IP strategy in numerous ways. For example, companies should disclose information about the patents in the drug list in a timely manner, making the public and government aware of the patents. Further, companies should also establish a multi-directional scheme for IP rights protection including not only patent, but also knowhow, trade secret, design, trademark and copyright.

Tesla: Can the Electric Car Company Overcome Its CEO’s Erratic (and Sometimes Illegal) Behavior?

November 12, 2018
Corporate Ethics, Regulatory, Securities Law

Joe Hallman, MJLST Staffer

Elon Musk, the ingenious and at times controversial CEO of Tesla, Inc., has been a fixture in the national news cycle of late with many questioning his erratic behavior. Musk has garnered negative attention recently for incidents ranging from publicly smoking marijuana to hurling wild accusations against critics on Twitter. However, Musk’s most significant faux pas in recent months was likely a tweet that resulted in him being charged with securities fraud by the Securities and Exchange Commission (“SEC”).

On August 7, 2018, Musk tweeted “Am considering taking Tesla private at $420. Funding secured.” The SEC sued Musk in federal court on September 27 for misleading investors with his tweet. Musk settled with the SEC two days later on September 29. The terms of the settlement required Musk to pay a $20 million personal fine and step down as chairman for three years, although he was allowed to remain CEO of the company. Although not charged with fraud, Tesla also settled with the SEC for $20 million.

Tesla’s stock price plummeted shortly after the SEC’s lawsuit was filed. Tesla shares were trading at about $305 prior to the lawsuit and on September 28, the day after the SEC filed suit, Tesla’s shares dropped to about $269. However, after that initial dip Tesla’s stock rebounded, eventually closing at $341.06 on November 6.

Many have questioned Tesla’s viability as a company over the years and it has been a common short sell among investors. However, considering Musk’s curious recent behavior, the stock price has been resilient. Meanwhile, on October 24, Tesla released its 2018 third-quarter earnings report showing surprise profits and positive cash flow. The earnings report is good news for shareholders who eagerly wait to see if Musk’s electric car company can eventually turn the corner and achieve a significantly higher market cap as Musk has promised.

Although Tesla seems to have been largely unaffected by the SEC’s lawsuit and other strange behavior by Musk, other top executives of publicly traded companies will likely take notice and learn from Tesla’s tumultuous past few months. Going forward, I would expect CEO’s of high-profile companies like Tesla to be careful about Twitter usage and seek to avoid negative attention in the press.

FDA’s Nutrition Innovation Strategy: The Right to Remain Silent on Added Sugars

November 5, 2018
Administrative Law, FDA, Food and Agriculture

Christina Petsoulis, MJLST Staffer

As of 2017, obesity rates in the United States reached 38.9%. It is without a doubt that poor diet is a major contributing factor to obesity prevalence. More specifically, diets consisting of convenience foods containing high amounts of added sugar serve as significant exposures leading to obesity and other comorbidities. A recent study reported that sugar was added to 66% of packaged foods.

While the sugar industry is quick to blame lack of physical activity for America’s obesity rates, research is clear that diets high in refined sugar increase the risk of obesity, cardiovascular disease, diabetes, fatty liver disease, cognitive decline and some cancers.

Though the linkages between food and obesity have been well established in scientific literature for some time, it is not until now that the Food and Drug Administration (FDA) has seriously recognized the importance of diet quality in chronic disease prevention.

On March 29, 2018, FDA commissioner, Dr. Scott Gotlieb, announced the Nutrition Innovation Strategy (NIS). Some of the key elements highlighted in the NIS include: modernizing claims, modernizing ingredient labels, modernizing standards of identity, implementing the nutrition facts label and menu labeling, and reducing sodium. The agency stated that it would be “committed to finding new ways to reduce the burden of chronic disease through improved nutrition.”

Gotlieb’s press release introducing the initiative seems to take a different perspective despite the agency’s intended goal.

In Gotlieb’s statement, he started by explaining the critical importance of a healthy diet in human health. He first introduced the importance of informed consumer choice as it relates to transparent labeling, then dove into the issue of “standards of identity.” Using milk as a key example, he explained that plant-based alternatives to cow’s milk, such as soy and almond-based beverages, labeled as “milk” create major public health concerns, including cases of kwashiorkor (protein deficiency disorder), and rickets (vitamin D deficiency disorder). He then went on to cite a case where a child was diagnosed with rickets as a result of parents assuming a soy-based beverage they fed their child contained the same nutritional qualities as cow’s milk. While the issue of standards of identity is relevant to public health nutrition in the context of protein deficiency and other forms of malnutrition, these issues have little relevance to obesity, or any other chronic disease for that matter.

It is surprising to see that Gotlieb’s press release does not highlight any of the important factors contributing to obesity in light of the initiative’s supposed goals. The worry, of course, is that the FDA is tip-toeing around food-industry players and, namely, the sugar industry in efforts to avoid conflict. The sugar industry is known for its aggressive efforts to shift blame for obesity on poor diet to lack of physical activity and poor consumer choice. For example, it was recently discovered that the sugar industry paid Harvard scientists to produce favorable results in their nutrition research on sugar’s role in heart disease.

While FDA has addressed the issue of sugar content through “added sugars” labeling requirements finalized in May 2016, little has been done to address sugar content in packaged foods. Serious efforts need to be taken to reduce sugar content in foods on the market to address the obesity epidemic

Artificial Intelligence as Inventors: Who or What Should Get the Patent?

November 5, 2018
Artificial Intelligence, Patents

Kelly Brandenburg, MJLST Staffer

Ever since the introduction of electronic computers, innovators across the world have focused on the development of artificial intelligence (“AI”), the goal being to enable machines to act like humans by making decisions and responding to situations. Generally considered to be the first artificial intelligence program, the Logic Theorist was designed in 1955 and enabled a machine to prove mathematical theorems. Since then, people have developed machines that have beat humans in some of the most strategic and intuitive games, such as Chess, Scrabble, Othello, Jeopardy, and Go.

As new innovations are developed, whether in AI or other areas of technology, patents are a common means for the inventors to protect their ideas. However, what happens when the AI technology advances to the point where the machines are making the innovations? Does the protection afforded to human inventions by Article I, Section 8 of the Constitution apply to new AI inventions? While this capability is still to be developed, the questions of patentability and patent ownership have been brought up previously, and will potentially need to be addressed by the United States Patent and Trademark Office (“USPTO”) in the future.

An initial question is whether the invention can even be patented. There are a variety of terms in patent statutes that indicate that the inventor has to be a human in order to get a patent, including “whoever,” “person,” and “inventor.” Therefore, if the invention is developed by a non-human entity, the same patent protection may not be applicable. However, assuming the inventions are patentable, then the next question is who should have the ownership rights to the patent. Should the AI itself get the patent, or should it instead go to the owner of the machine, or maybe to the inventor/programmer of the AI program?

The main purpose of providing patents to inventors is to “promote the progress of science and useful arts” by allowing the inventors to exclusively benefit from their efforts; it is an incentive-based program. From the AI perspective, there would not be much benefit in providing the AI with the exclusive rights of a patent, assuming the AI does not desire the money, recognition, or any other benefit that might come with it. Its innovation is more likely to be due to the natural development of its programming over time, rather than the incentivization of any reward it might get. However, since this technology is still being developed, maybe AI will learn to act similar to humans when it comes to incentives, which would then mean that giving it a patent could induce more innovative efforts.

For owners, depending on how the owner uses and interacts with the AI, the ownership rights of a patent may or may not have its desired effect. If the owner has the desire to use the AI to potentially invent something and exposes it to unique environments or equipment, then perhaps they deserve the exclusive rights to the AI’s patent. However, if the AI just happens to invent something with no direction or intent of the owner, it would not make much sense to reward the owner for exerting no effort.

Lastly, the patent could also go to the initial programmers of the AI. This would also likely depend on whether or not enough effort was put into the development of the AI after its initial programming. When the owner puts in the effort, then the owner might get the patent over the programmer, but if the AI just happens to invent something regardless of what the owner does, then the programmer could have rights to the patent. Again, if programmers would benefit from the AI’s invention, that would incentivize the programmers to further enhance their programs.

Since these specific capabilities are mostly hypothetical at this point, it is impossible to predict exactly how the AI technology is going to advance, and actually work, in the future. However, the technology is definitely changing and getting closer to making AI innovation a reality, and patent law will have to adapt to however it unfolds.

November 2018

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